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Platinum-resistant Ovarian Cancer (PROC)Phase 4RIFOC003NCT07075250

Safety and Efficacy of RIF Combined With Anlotinib in the Treatment of Patients With Advanced Recurrent Platinum-Resistant Ovarian Cancer: A Prospective, Multicenter Clinical Study

A Phase 4 study testing Realgar-Indigo Naturalis Formulation Combined with Anlotinib in people with Platinum-resistant Ovarian Cancer (PROC), run by Peking University People's Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This project plans to conduct a prospective, multicenter clinical study. The intended participants are patients with histologically confirmed advanced (FIGO III/IV stage) ovarian serous carcinoma, ovarian endometrioid carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma who have platinum-resistant… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Platinum-resistant Ovarian Cancer (PROC)
What is being tested?
Realgar-Indigo Naturalis Formulation Combined with Anlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Sep 2025to 31 Dec 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient voluntarily participates in this study and signs the informed consent form.
  • Female aged 18-70 years.
  • Histologically confirmed advanced (FIGO stage III/IV) serous or ovarian endometrioid carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma.
  • Disease recurrence within 6 months after the last platinum-based chemotherapy or progression during chemotherapy (i.e., platinum-resistant or platinum-refractory).
  • ECOG performance status of 0 or 1, with an expected survival of ≥4 months.
  • Adequate organ function, meeting the following laboratory criteria within 14 days before enrollment:
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  • Complete blood count (without transfusion within 14 days):
  • Hemoglobin (Hb) ≥80 g/L;
  • Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
  • Platelet count (PLT) ≥80×10⁹/L.
  • Biochemical tests:
  • Total bilirubin ≤1.5×ULN (upper limit of normal);
  • ALT and AST ≤2.5×ULN (≤5×ULN if liver metastases are present);
  • Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula).
  • Cardiac function: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
  • Ability to take oral medications.
  • ≥4 weeks since the last chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other antitumor treatments before the first dose of study drugs.
  • Women of childbearing potential must agree to use highly effective contraception during the study and for 6 months after the last dose. A negative serum or urine pregnancy test within 7 days before enrollment is required, and the patient must be non-lactating.

Who cannot join

  • 1. Prior treatment with arsenic agents (e.g., arsenic trioxide, Compound Huangdai Tablets) or anlotinib hydrochloride/other targeted therapies.
  • 2. Known hypersensitivity to anlotinib or its excipients. 3. Known hypersensitivity to arsenic agents or their excipients. 4. Comorbidities/medical history:
  • Clinically significant hemoptysis (>50 mL/day within 3 months before enrollment) or active bleeding (e.g., gastrointestinal hemorrhage, hemorrhagic gastric ulcer, baseline fecal occult blood ≥++), or vasculitis.
  • Arterial/venous thromboembolic events within 6 months (e.g., cerebrovascular accident, deep vein thrombosis [unless catheter-related and resolved], pulmonary embolism).
  • Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg despite medication) or history within 6 months of myocardial infarction, severe/unstable angina, NYHA class ≥2 heart failure, clinically significant arrhythmias, or symptomatic congestive heart failure.
  • Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., pulmonary fibrosis, acute pneumonia).
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  • Renal insufficiency: urine protein ≥++ or 24-hour urine protein ≥1.0 g.
  • Live attenuated vaccination within 28 days before the first dose or planned during the study.
  • HIV infection or AIDS; active hepatitis (HBV-DNA ≥500 IU/mL; HCV-RNA above detection limit) or coinfection with HBV/HCV.
  • Severe infection within 4 weeks (e.g., bacteremia, severe pneumonia requiring hospitalization) or active infection (CTCAE ≥grade 2) requiring systemic antibiotics within 2 weeks; unexplained fever >38.5°C during screening (unless tumor-related per investigator); active tuberculosis within 1 year.
  • Other malignancies within 3 years (except adequately treated basal cell carcinoma, squamous cell skin cancer, or cervical carcinoma in situ).
  • Palliative radiotherapy to >20% bone marrow within 1 week; history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • Major surgery within 28 days (diagnostic biopsies or PICC placement allowed).
  • Prior or planned allogeneic bone marrow or solid organ transplantation.
  • Peripheral neuropathy ≥grade 2; active brain metastases, leptomeningeal disease, or spinal cord compression (stable brain metastases treated ≥14 days before enrollment allowed if no hemorrhage on MRI/CT).
  • 5. Current/recent (within 30 days) use of another investigational drug or participation in another clinical trial.
  • 6. Conditions severely affecting oral drug absorption (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
  • 7. Any condition that may interfere with study results or compliance, per investigator judgment.

About this study

Official title: Safety and Efficacy of Realgar-Indigo Naturalis Formula（RIF） Combined With Anlotinib in the Treatment of Patients With Advanced Recurrent Platinum-Resistant Ovarian Cancer: A Prospective, Multicenter Clinical Study

This project plans to conduct a prospective, multicenter clinical study. The intended participants are patients with histologically confirmed advanced (FIGO III/IV stage) ovarian serous carcinoma, ovarian endometrioid carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma who have platinum-resistant recurrence or are platinum-refractory (n=30). The study design is a single-arm study. The treatment regimen for the study group is the RIF combined with anlotinib group, with continuous administration until disease progression, death, intolerable toxicity, loss to follow-up, withdrawal of informed consent, or study termination, whichever occurs first. The treatment duration will not exceed 18 months, with a follow-up period of 24 months.

The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life score (QOL), and safety. The primary efficacy evaluation will use imaging methods (RECIST 1.1) combined with tumor marker CA125 levels.

Read more

All data in this study will be summarized using appropriate statistical measures based on data type: continuous data will be described using mean, standard deviation (STD), median, minimum, and maximum, while categorical data will be summarized using frequency and percentage (proportion). Time-to-event data will be analyzed using the Kaplan-Meier (KM) product-limit method to estimate median survival time, with survival curves plotted and 95% confidence intervals for median time estimated when necessary.

This study aims to evaluate the efficacy and safety of RIF combined with anlotinib in patients with platinum-resistant recurrent ovarian cancer, providing a new therapeutic strategy.

Being tested
Realgar-Indigo Naturalis Formulation Combined with Anlotinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Realgar-Indigo Naturalis Formulation Combined with AnlotinibDrug

    Also called anlotinib

    RIF: Oral administration after meals, 6 tablets each time, three times daily (tid), from day 1 to day 14 (d1-14), every 3 weeks (q3w), continuous dosing.

    Anlotinib : Oral administration before breakfast, 10 mg each time, once daily (qd), from day 1 to day 14 (d1-14), every 3 weeks (q3w), continuous dosing.

    Subjects will continue the study treatment until meeting the protocol-defined discontinuation criteria. The total treatment duration should not exceed 18 months.

Study groups in NCT07075250
Study groupRoleWhat they receive
RIF Combined with AnlotinibExperimentalNot described
Receives: Drug: Realgar-Indigo Naturalis Formulation Combined with Anlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS(Progression-Free Survival)

    Measured: Evaluation at 3 months, 6 months, and 12 months of treatment

Secondary outcomes (5)

  1. OS(Overall Survival)

    Measured: Evaluation at 3 months, 6 months, 12 months and 24 month of treatment

  2. ORR(Objective Response Rate)

    Measured: Evaluation at 3 months, 6 months, and 12 months of treatment

  3. DCR((Disease Control Rate))

    Measured: Evaluation at 3 months, 6 months, and 12 months of treatment

  4. QOL（Quality Of Life）

    The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) is a widely used tool to assess the health-related quality of life (HRQoL) in cancer patients.

    1. Global Health Status/Quality of Life ≥70 points: Good quality of life (close to healthy population). 50-69 points: Moderate, with possible minor impact. <50 points: Poor, requiring clinical intervention.
    2. Functional Scales Physical Functioning (PF): Low scores indicate limitations in daily activities. Emotional Functioning (EF): Low scores suggest anxiety/depression risk, warranting psychological intervention. Social Functioning (SF): Low scores reflect negative disease impact on interpersonal relationships.
    3. Symptom Scales Fatigue (FA): Scores >50 indicate a need to evaluate anemia or treatment side effects.

    Pain (PA): Scores >40 require initiation of pain management. Nausea/Vomiting (NV): Scores >30 necessitate antiemetic regimen adjustment.

    Measured: According to the EORTC QLQ-C30 criteria, evaluations were carried out at 3, 6, and 12 months of treatment.

  5. AE(Adverse Event) assessment

    Measured: During the study up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07075250
Sponsor's protocol ID
2025PHD008-001
Acronym
RIFOC003
Status last verified
Jul 2025
First submitted
25 Jun 2025
Last updated
20 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Realgar-Indigo Naturalis Formulation Combined with Anlotinib in people with Platinum-resistant Ovarian Cancer (PROC), run by Peking University People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS(Progression-Free Survival) (time frame: Evaluation at 3 months, 6 months, and 12 months of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07075250.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.

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